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FDA 510(k) Application Details - K142666
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K142666
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
Delta International Services & Logistics S.r.l
Piazza Cavour 17
Rome 00193 IT
Other 510(k) Applications for this Company
Contact
Donatella Ruscito
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/18/2014
Decision Date
05/22/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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